Navigable catheter

ABSTRACT

A catheter, including: a housing having a transverse inner dimension of at most about two millimeters; and a coil arrangement including five coils and five solid cores. Each of the coils is wound around one of the solid cores. The coils are non-coaxial. The coil arrangement is mounted inside the housing.

This is a Divisional of U.S. Ser. No. 09/463,177, filed Jun. 21, 2000.

FIELD AND BACKGROUND OF THE INVENTION

The present invention relates to electromagnetic tracking devices and,more particularly, to a system and method for tracking a medical probesuch as a catheter as the probe is moved through the body of a patient.

It is known to track the position and orientation of a moving objectwith respect to a fixed frame of reference, by equipping the movingobject with a transmitter that transmits electromagnetic radiation,placing a receiver in a known and fixed position in the fixed frame ofreference, and inferring the continuously changing position andorientation of the object from signals transmitted by the transmitterand received by the receiver. Equivalently, by the principle ofreciprocity, the moving object is equipped with a receiver, and atransmitter is placed in a known and fixed position in the fixed frameof reference. Typically, the transmitter includes three orthogonalmagnetic dipole transmitting antennas; the receiver includes threeorthogonal magnetic dipole receiving sensors; and the object is closeenough to the stationary apparatus (transmitter or receiver), and thefrequencies of the signals are sufficiently low, that the signals arenear field signals. Also typically, the system used is a closed loopsystem: the receiver is hardwired to, and explicitly synchronized with,the transmitter. Representative prior art patents in this field includeU.S. Pat. No. 4,287,809 and U.S. Pat. No. 4,394,831, to Egli et al.;U.S. Pat. No. 4,737,794, to Jones; U.S. Pat. No. 4,742,356, to Kuipers;U.S. Pat. No. 4,849,692, to Blood; and U.S. Pat. No. 5,347,289, toElhardt. Several of the prior art patents, notably Jones, presentnon-iterative algorithms for computing the position and orientation ofmagnetic dipole transmitters with respect to magnetic dipole receivers.

An important variant of such systems is described in U.S. Pat. No.5,600,330, to Blood. In Blood's system, the transmitter is fixed in thefixed reference frame, and the receiver is attached to the movingobject. Blood's transmitting antennas are spatially extended, and socannot be treated as point sources. Blood also presents an algorithmwhich allows the orientation, but not the position, of the receiverrelative to the transmitter to be calculated non-iteratively.

Systems similar to Blood's are useful for tracking a probe, such as acatheter or an endoscope, as that probe is moved through the body of amedical patient. It is particularly important in this application thatthe receiver be inside the probe and that the transmitter be external tothe patient, because transmitting antennas of sufficient power would notfit inside the confined volume of the probe. A representative prior artsystem of this type is described in PCT Publication WO 96/05768,entitled “Medical Diagnosis, Treatment and Imaging Systems”, which isincorporated by reference for all purposes as if fully set forth herein.Medical applications of such systems include cismyocardialrevascularization, balloon catheterization, stent emplacement,electrical mapping of the heart and the insertion of nerve stimulationelectrodes into the brain.

Perhaps the most important application of this tracking is to intrabodynavigation, as described by Acker in U.S. Pat. No. 5,729,129, withreference to PCT Publication No. WO 95/09562. A three-dimensional image,such as a CT or MRI image, of the patient is acquired. This imageincludes fiducial markers at predetermined fiducial points on thesurface of the patient. Auxiliary receivers similar to the receiver ofthe probe are placed at the fiducial points. The signals received by theauxiliary receivers are used to register the image with respect to thetransmitter frame of reference, so that an icon that represents theprobe can be displayed, superposed on a slice of the image, with thecorrect position and orientation with respect to the image. In this way,a physician can see the position and orientation of the probe withrespect to the patient's organs.

WO 96/05768 illustrates another constraint imposed on such systems bythe small interior dimensions of the probe. In most prior art systems,for example, the system of Egli et al., the receiver sensors are threeconcentric orthogonal coils wound on a ferrite core. The coils are“concentric” in the sense that their centers coincide. Such a receiverof sufficient sensitivity would not fit inside a medical probe.Therefore, the sensor coils of WO 96/05768 are collinear: the threeorthogonal coils are positioned one behind the other, with their centerson the axis of the probe, as illustrated in FIG. 3 of WO 96/05768. Thisreduces the accuracy of the position and orientation measurements,because instead of sensing three independent magnetic field componentsat the same point in space, this receiver senses three independentmagnetic field components at three different, albeit closely spaced,points in space.

A further, consequent concession of the system of WO 96/05768 to thesmall interior dimensions of a catheter is the use of coils wound on aircores, rather than the conventional ferrite cores. The high mutualcoupling of collinear coils wound on ferrite cores and measuring threeindependent field components at three different points in space woulddistort those measurements sufficiently to make those measurementsfatally nonrepresentative of measurements at a single point.

Another drawback of the system of WO 96/05768 relates to the geometry ofthe transmitter antennas. These are three nonoverlapping flat coplanarcoils, preferably arranged in a triangle. Because the strength of thefield transmitted by one of these coils falls as the reciprocal cube ofthe distance from the coil, the receiver usually senses fields of verydisparate strength, which further degrades the accuracy of the positionand orientation measurements. Acker addresses this problem byautomatically boosting the power supplied to transmitting coils far fromthe receiver. In U.S. Pat. No. 5,752,513, Acker et al. address thisproblem by overlapping the coplanar transmitting coils.

Acker et al. transmit time-multiplexed DC signals. This timemultiplexing slows down the measurement. Frequency multiplexing, astaught in WO 96/05768, overcomes this problem, but introduces a newproblem insofar as the transmitting coils are coupled by mutualinductance at non-zero transmission frequency, so that the transmittedfield geometry is not the simple geometry associated with a single coil,but the more complex geometry associated with several coupled coils.This complicates and slows down the calculation of the position andorientation of the receiver relative to the transmitter coils. PCTPublication WO 97/36143, entitled “Mutual Induction Correction”,addresses this problem by generating, at each transmitter coil,counter-fields that cancel the fields generated by the other transmittercoils.

A further source of slowness in calculating the position and orientationof the receiver is the iterative nature of the calculation required fora spatially extended transmitter. As noted above, Blood calculates theposition of the receiver iteratively. Even in the DC case, Acker et al.calculate both the position and the orientation of the receiveriteratively.

There is thus a widely recognized need for, and it would be highlyadvantageous to have, a faster and more accurate method for tracking amedical probe inside the body of a patient.

SUMMARY OF THE INVENTION

According to the present invention there is provided a system fortracking a position and an orientation of a probe, including a pluralityof first sensors, each of the first sensors for detecting a differentcomponent of a vector force field, each of the first sensors includingtwo sensor elements disposed symmetrically about a common referencepoint in the probe, the first sensors being mounted inside the probe.

According to the present invention there is provided a method fordetermining a position and an orientation of an object with respect to areference frame, including the steps of: (a) providing the object withthree independent sensors of electromagnetic radiation; (b) providingthree independent transmitting antennas of the electromagneticradiation, each of the transmitting antennas having a fixed position inthe reference frame, at least one of the transmitting antennas beingspatially extended; (c) transmitting the electromagnetic radiation,using the transmitting antennas, a first of the transmitting antennastransmitting the electromagnetic radiation of a first spectrum, a secondof the transmitting antennas transmitting the electromagnetic radiationof a second spectrum independent of the first spectrum, and a third ofthe transmitting antennas transmitting the electromagnetic radiation ofa third spectrum independent of the first spectrum; (d) receivingsignals corresponding to the electromagnetic radiation, at all three ofthe sensors, at a plurality of times, in synchrony with the transmittingof the electromagnetic radiation; and (e) inferring the position and theorientation of the object noniteratively from the signals.

According to the present invention there is provided a system fordetermining a position and an orientation of an object, including: (a) aplurality of at least partly overlapping transmitter antennas; (b) amechanism for exciting the transmitter antennas to transmitelectromagnetic radiation simultaneously, the electromagnetic radiationtransmitted by each of the transmitter antennas having a differentspectrum; (c) at least one electromagnetic field sensor, associated withthe object, operative to produce signals corresponding to theelectromagnetic radiation; and (d) a mechanism for inferring theposition and the orientation of the object from the signals.

According to the present invention there is provided a system fordetermining a position and an orientation of an object, including: (a) aplurality of at least partly overlapping transmitter antennas; (b) amechanism for exciting each of the transmitter antennas to transmitelectromagnetic radiation of a certain single independent frequency andphase, the mechanism including, for each of the transmitter antennas, amechanism for decoupling the each transmitter antenna from theelectromagnetic radiation transmitted by every other transmitterantenna; (c) at least one electromagnetic field sensor, associated withthe object, operative to produce signals corresponding to theelectromagnetic radiation; and (d) a mechanism for inferring theposition and the orientation of the object from the signals.

According to the present invention there is provided a catheter,including: (a) a housing having a transverse inner dimension of at mostabout two millimeters; and (b) at least one coil, wound about a solidcore, mounted inside the housing.

According to the present invention there is provided a system fornavigating a probe inside a body, including: (a) a receiver ofelectromagnetic radiation, inside the probe; (b) a device for acquiringan image of the body; and (c) a transmitter, of the electromagneticradiation, including at least one antenna rigidly attached to the deviceso as to define a frame of reference that is fixed with respect to thedevice.

According to the present invention there is provided a system fornavigating a probe inside a body, including: (a) a first receiver ofelectromagnetic radiation, inside the probe; (b) a device for acquiringan image of the body; and (c) a second receiver, of the electromagneticradiation, rigidly attached to the device so as to define a frame ofreference that is fixed with respect to the device.

According to the present invention there is provided a method ofnavigating a probe inside a body, including the steps of: (a) providinga device for acquiring an image of the body; (b) simultaneously: (i)acquiring the image of the body, and (ii) determining a position andorientation of the probe with respect to the image; and (c) displayingthe image of the body with a representation of the probe superposedthereon according to the position and the orientation.

According to the present invention there is provided a device forsensing an electromagnetic field at a point, including at least foursensing elements, at least two of the sensing elements being disposedeccentrically with respect to the point.

According to the present invention there is provided a method fordetermining a position and an orientation of an object with respect to areference frame, including the steps of: (a) providing the object withthree independent sensors of electromagnetic radiation; (b) providingthree independent transmitting antennas of the electromagneticradiation, each of the transmitting antennas having a fixed position inthe reference frame, at least one of the transmitting antennas beingspatially extended; (c) transmitting the electromagnetic radiation,using the transmitting antennas, a first of the transmitting antennastransmitting the electromagnetic radiation of a first spectrum, a secondof the transmitting antennas transmitting the electromagnetic radiationof a second spectrum independent of the first spectrum, and a third ofthe transmitting antennas transmitting the electromagnetic radiation ofa third spectrum independent of the first spectrum; (d) receivingsignals corresponding to the electromagnetic radiation, at all three ofthe sensors, at a plurality of times, in synchrony with the transmittingof the electromagnetic radiation; (e) setting up an overdetermined setof linear equations relating the signals to a set of amplitudes, therebeing, for each of the sensors: for each transmitting antenna: one ofthe amplitudes; and (f) solving the set of linear equations for theamplitudes.

According to the present invention there is provided a method ofnavigating a probe inside a body, including the steps of: (a) providinga device for acquiring an image of the body; (b) simultaneously: (i)acquiring the image of the body, and (ii) determining a position and anorientation of the body with respect to the image; (c) determining aposition and an orientation of the probe with respect to the body; and(d) displaying the image of the body with a representation of the probesuperposed thereon according to both of the positions and both of theorientations.

According to the present invention there is provided a device forsensing an electromagnetic field at a point, including: (a) two sensingelements, each of the sensing elements including a first lead and asecond lead, the first leads being electrically connected to each otherand to ground; and (b) a differential amplifier, each of the secondleads being electrically connected to a different input of thedifferential amplifier.

According to the present invention there is provided a catheterincluding: (a) an outer sleeve having an end; (b) an inner sleeve havingan end and slidably mounted within the outer sleeve; (c) a firstflexible member connecting the end of the outer sleeve to the end of theinner sleeve; and (d) a first coil mounted on the first flexible member.

According to the present invention there is provided a system fordetermining a position and an orientation of an object, including:(a) atleast one transmitter antenna for transmitting an electromagnetic field;(b) a first electromagnetic field sensor, associated with the object andincluding two sensing elements responsive to a first component of thetransmitted electromagnetic field, each of the sensing elementsincluding a first lead and a second lead, the first leads beingelectrically connected to each other and to ground; and (c) a firstdifferential amplifier, each of the second leads being electricallyconnected to a different input of the first differential amplifier.

According to the present invention there is provided an imaging device,including: (a) an electrically conducting surface; (b) a magneticallypermeable compensator; and (c) a mechanism for securing the compensatorrelative to the surface so as to substantially suppress a distortion ofan external electromagnetic field caused by the surface.

According to the present invention there is provided a device forsensing an electromagnetic field, including: (a) a housing, including afirst pair of diametrically opposed apertures, (b) a first core mountedin the first pair of apertures; and (c) a first coil of electricallyconductive wire wound about the core.

According to the present invention there is provided a probe forinteracting with a body cavity, including: (a) a substantiallycylindrical catheter; (b) a satellite; and (c) a mechanism forreversibly securing the satellite at a fixed position and orientationrelative to the catheter after the catheter and the satellite have beeninserted into the body cavity.

Each receiver sensor of the present invention includes two sensorelements placed symmetrically with respect to a reference point insidethe probe. All the sensor element pairs share the same reference point,so that the measured magnetic field components are representative of thefield component values at the single reference point, instead of atthree different points, as in the prior art system, despite the confinedtransverse interior dimensions of the probe. Because of the symmetricdisposition of the sensor elements with respect to the reference point,the measured magnetic field components are representative of the fieldcomponents at the reference point, despite the individual sensingelements not being centered on the reference point. This property of notbeing centered on the reference point is termed herein an eccentricdisposition with respect to the reference point.

In one preferred embodiment of the receiver of the present invention,the sensor elements are helical coils. Within each sensor, the coils aremutually parallel and connected in series. As in the case of the priorart receivers, the coils are arranged with their centers on the axis ofthe probe. To ensure that coils of different sensors are mutuallyperpendicular, the probe housing includes mutually perpendicular pairsof diametrically opposed apertures formed therein, the coils whose axesare perpendicular to the axis of the probe are wound about cores whoseends extend past the ends of the respective coils, and the ends of thecores are mounted in their respective apertures.

In another preferred embodiment of the receiver of the presentinvention, with three sensors, the sensor elements are flat rectangularcoils bent to conform to the shape of the cylindrical interior surfaceof the probe. The sensor elements of the three sensors are interleavedaround the cylindrical surface. The advantage of this preferredembodiment over the first preferred embodiment is that this preferredembodiment leaves room within the probe for the insertion of othermedical apparati.

As noted above, within any one sensor, the coils are connected inseries. This connection is grounded. The other end of each coil isconnected, by one wire of a twisted pair of wires, to a different inputof a differential amplifier.

In a preferred embodiment of a cardiac catheter that incorporates areceiver of the present invention, the catheter includes an inner sleevemounted slidably within an outer sleeve. One of the sensors includes twocoils mounted within the inner sleeve, towards the distal end of thecatheter. The distal end of the inner sleeve is connected to the distalend of the outer sleeve by flexible strips. Each of the other sensorsincludes two coils mounted on opposed lateral edges of a pair offlexible strips that flank the inner sleeve, with the inner sleeverunning between the two members of the pair. When the inner sleeve is inthe extended position thereof relative to the outer sleeve, the flexiblestrips lie flat against the inner sleeve, and the catheter can bemaneuvered towards a patient's heart via the patient's blood vessels.When the end of the catheter has been introduced to the targeted chamberof the heart, the inner sleeve is withdrawn to the retracted positionthereof relative to the outer sleeve, and the pairs of flexible stripsform circles that are concentric with the reference point. Also mountedon the outward-facing surfaces of the flexible strips and, optionally,on the distal end of the inner sleeve, are electrodes forelectrophysiologic mapping of the heart. Alternatively, the electrode onthe distal end of the inner sleeve may be used for ablation of cardiactissue, for example in the treatment of ventricular tachycardia.

An alternative preferred embodiment of the cardiac catheter of thepresent invention has an inflatable balloon connecting the distal endsof the inner and outer sleeves. The coils of the external sensors aremounted on the external surface of the balloon. When the inner sleeve isin the extended position thereof relative to the outer sleeve, theballoon lies flat against the inner sleeve, and the catheter can bemaneuvered towards the patient's heart via the patient's blood vessels.When the end of the catheter has been introduced to the targeted chamberof the heart, the inner sleeve is withdrawn to the retracted positionthereof relative to the outer sleeve, and the balloon is inflated to asphere that is concentric with the reference point.

Although the primary application of the receiver of the presentinvention is to tracking a probe by receiving externally generatedelectromagnetic radiation, the scope of the present invention includesreceivers for similar tracking based on the reception of any externallygenerated vector force field, for example, a time varying isotropicelastic field.

The algorithm of the present invention for inferring the position andorientation of the receiver with respect to the transmitter is similarto the algorithm described in co-pending Israel Patent Application122578. The signals received by the receiver are transformed to a 3×3matrix M. The columns of M correspond to linear combinations of theamplitudes of the transmitted fields. The rows of M correspond to thereceiver sensors. A rotationally invariant 3×3 position matrix W and a3×3 rotation matrix Tare inferred noniteratively from the matrix M. TheEuler angles that represent the orientation of the receiver relative tothe transmitter antennas are calculated noniteratively from the elementsof T, and the Cartesian coordinates of the receiver relative to thetransmitter antennas are calculated from the elements of W A preliminarycalibration of the system, either by explicitly measuring the signalsreceived by the receiver sensors at a succession of positions andorientations of the receiver, or by theoretically predicting thesesignals at the successive positions and orientations of the receiver, isused to determine polynomial coefficients that are used in thenoniterative calculation of the Euler angles and the Cartesiancoordinates. In essence, the extra time associated with an iterativecalculation is exchanged for the extra time associated with an initialcalibration. One simplification of the algorithm of the presentinvention, as compared to the algorithm of IL 122578, derives from thefact that the system of the present invention is a closed loop system.

The preferred arrangement of the transmitter antennas of the presentinvention is as a set of flat, substantially coplanar coils that atleast partially overlap. Unlike the preferred arrangement of Acker etal., it is not necessary that every coil overlap every other coil, aslong as each coil overlaps at least one other coil. The most preferredarrangement of the transmitter antennas of the present inventionconsists of three antennas. Two of the antennas are adjacent and definea perimeter. The third antenna partly follows the perimeter and partlyoverlaps the first two antennas. The elements of the first column of Mare sums of field amplitudes imputed to the first two antennas. Theelements of the second column of M are differences of field amplitudesimputed to the first two antennas. The elements of the third column of Mare linear combinations of the field amplitudes imputed to all threeantennas that correspond to differences between the field amplitudesimputed to the third antenna and the field amplitudes that would beimputed to a fourth antenna that overlaps the portion of the first twoantennas not overlapped by the third antenna.

The signals transmitted by the various antennas of the present inventionhave different, independent spectra. The term “spectrum”, as usedherein, encompasses both the amplitude and the phase of the transmittedsignal, as a function of frequency. So, for example, if one antennatransmits a signal proportional to cos ωt and another antenna transmitsa signal proportional to sin ωt, the two signals are said to haveindependent frequency spectra because their phases differ, even thoughtheir amplitude spectra both are proportional to δ(ω). The term“independent spectra”, as used herein, means that one spectrum is notproportional to another spectrum. So, for example, if one antennatransmits a signal equal to cosωt and another antenna transmits a signalequal to 2 cos ωt, the spectra of the two signals are not independent.Although the scope of the present invention includes independenttransmitted signals that differ only in phase, and not in frequency, theexamples given below are restricted to independent transmitted signalsthat differ in their frequency content.

The method employed by the present invention to decouple thetransmitting antennas, thereby allowing each antennas to transmit atonly a single frequency different from the frequencies at which theother antennas transmit, or, alternatively, allowing two antennas totransmit at a single frequency but with a predetermined phaserelationship between the two signals, is to drive the antennas withcircuitry that makes each antenna appear to the fields transmitted bythe other antennas as an open circuit. To accomplish this, the drivingcircuitry of the present invention includes active circuit elements suchas differential amplifiers, unlike the driving circuitry of the priorart, which includes only passive elements such as capacitors andresistors. By “driving circuitry” is meant the circuitry that imposes acurrent of a desired transmission spectrum on an antenna, and not, forexample, circuitry such as that described in WO 97/36143 whose functionis to detect transmissions by other antennas with other spectra andgenerate compensatory currents.

With respect to intrabody navigation, the scope of the present inventionincludes the simultaneous acquisition and display of an image of thepatient and superposition on that display of a representation of a probeinside the patient, with the representation positioned and oriented withrespect to the image in the same way as the probe is positioned andoriented with respect to the patient. This is accomplished bypositioning and orienting the imaging device with respect to the frameof reference of the transmitter, in one of two ways. Either thetransmitter antennas are attached rigidly to the imaging device, or asecond receiver is attached rigidly to the imaging device and theposition and orientation of the imaging device with respect to thetransmitter are determined in the same way as the position andorientation of the probe with respect to the transmitter are determined.This eliminates the need for fiducial points and fiducial markers. Thescope of the present invention includes both 2D and 3D images, andincludes imaging modalities such as CT, MRI, ultrasound and fluoroscopy.Medical applications to which the present invention is particularlysuited include transesophageal echocardiography, intravascularultrasound and intracardial ultrasound. In the context of intrabodynavigation, the term “image” as used herein refers to an image of theinterior of the patient's body, and not to an image of the patient'sexterior.

Under certain circumstances, the present invention facilitates intrabodynavigation even if the image is acquired before the probe is navigatedthrough the patient's body with reference to the image. A third receiveris attached rigidly to the limb of the patient to which the medicalprocedure is to be applied. During image acquisition, the position andorientation of the third receiver with respect to the imaging device isdetermined as described above. This determines the position andorientation of the limb with respect to the image. Subsequently, whilethe probe is being moved through the limb, the position and orientationof the probe with respect to the limb is determined using the secondmethod described above to position and orient the probe with respect tothe imaging device during simultaneous imaging and navigation. Given theposition and orientation of the probe with respect to the limb and theorientation and position of the limb with respect to the image, it istrivial to infer the position and orientation of the probe with respectto the image.

Many imaging devices used in conjunction with the present inventioninclude electrically conducting surfaces. One important example of suchan imaging device is a fluoroscope, whose image intensifier has anelectrically conducting front face. According to the present invention,the imaging device is provided with a magnetically permeable compensatorto suppress distortion of the electromagnetic field near theelectrically conducting surface as a consequence of eddy currentsinduced in the electrically conducting surface by the electromagneticwaves transmitted by the transmitting antennas of the present invention.

The scope of the present invention includes a scheme for retrofitting anapparatus such as the receiver of the present invention to a catheter toproduce an upgraded probe for investigating or treating a body cavity ofa patient. A tether provides a loose mechanical connection between theapparatus and the catheter while the apparatus and the catheter areinserted into the patient. When the apparatus and the catheter reachtargeted body cavity, the tether is withdrawn to pull the apparatus intoa pocket on the catheter. The pocket holds the apparatus in a fixedposition and orientation relative to the catheter.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention is herein described, by way of example only, withreference to the accompanying drawings, wherein:

FIG. 1 is a schematic diagram of a system of the present invention;

FIG. 2A is a partly cut away perspective view of a probe and a receiver;

FIG. 2B is a circuit diagram of the receiver of FIG. 2A;

FIG. 2C illustrates features of the receiver of FIG. 2A that suppressunwanted electromagnetic coupling;

FIG. 3 is an axial sectional view of a probe and a receiver;

FIG. 4A shows two coils of opposite helicities;

FIG. 4B shows two coils of identical helicities;

FIG. 5 shows a second preferred embodiment of a receiver;

FIG. 6 is a plan view of three loop antennas and two phantom loopantennas;

FIGS. 7A, 7B and 7C show alternative configurations of paired adjacentloop antennas;

FIG. 8 is a schematic block diagram of driving circuitry

FIG. 9 shows a C-mount fluoroscope modified for real-time intrabodynavigation

FIG. 10 shows a coil of the receiver of FIG. 5;

FIG. 11 shows a CT scanner modified for imaging in support of subsequentintracranial navigation;

FIG. 12A is a partly cut-away perspective view of a cardiac catheter ofthe present invention in the retracted position thereof;

FIG. 12B is a perspective view of the catheter of FIG. 12A in theextended position thereof;

FIG. 12C is an end-on view of the catheter of FIG. 12 a in the retractedposition thereof;

FIG. 13A is a partly cut-away side view of a second embodiment of thecardiac catheter of the present invention in the retracted and inflatedposition thereof;

FIG. 13B is an end-on view of the catheter of FIG. 13A in the retractedand inflated position thereof;

FIG. 14 is a partial perspective view of the C-mount fluoroscope of FIG.9, including a magnetically permeable compensator;

FIG. 15 is a partial exploded perspective view of a preferred embodimentof the probe and receiver of FIG. 2A;

FIG. 16 illustrates a scheme for retrofitting an apparatus such as thereceiver of FIG. 2A to a catheter.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention is of a system and method for tracking theposition and orientation of an object relative to a fixed frame ofreference. Specifically, the present invention can be used to track themotion of a medical probe such as a catheter or an endoscope within thebody of a patient.

The principles and operation of remote tracking according to the presentinvention may be better understood with reference to the drawings andthe accompanying description.

Referring now to the drawings, FIG. 1 illustrates, in general terms, asystem of the present invention. Within a probe 10 is rigidly mounted areceiver 14. Receiver 14 includes three field component sensors 16, 18,and 20, each for sensing a different component of an electromagneticfield. Sensor 16 includes two sensor elements 16 a and 16 b. Sensor 18includes two sensor elements 18 a and 18 b. Sensor 20 includes twosensor elements 20 a and 20 b. Typically, the sensor elements are coils,and the sensed components are independent magnetic field components.Sensor elements 16 a and 16 b are on opposite sides of, and equidistantfrom, a common reference point 22. Similarly, sensor elements 18 a and18 b are on opposite sides of, and equidistant from, point 22, andsensor elements 20 a and 20 b also are on opposite sides of, andequidistant from, point 22. In the illustrated example, sensors 16, 18and 20 are disposed collinearly along a longitudinal axis 12 of probe10, but other configurations are possible, as discussed below.

The system of FIG. 1 also includes a transmitter 24 of electromagneticradiation. Transmitter 24 includes three substantially coplanarrectangular loop antennas 26, 28 and 30 connected to driving circuitry32. Loop antennas 26 and 28 are adjacent and are partly overlapped byloop antenna 30. Driving circuitry 32 includes appropriate signalgenerators and amplifiers for driving each of loop antennas 26, 28 and30 at a different frequency. The electromagnetic waves generated bytransmitter 24 are received by receiver 14. The signals from receiver 14that correspond to these electromagnetic waves are sent to receptioncircuitry 34 that includes appropriate amplifiers and A/D converters.Reception circuitry 34 and driving circuitry 32 are controlled by acontroller/processor 36 that typically is an appropriately programmedpersonal computer. Controller/processor 36 directs the generation oftransmitted signals by driving circuitry 32 and the reception ofreceived signals by reception circuitry 34. Controller/processor 36 alsoimplements the algorithm described below to infer the position andorientation of probe 10. Note that the system of FIG. 1 is a closed-loopsystem: the reception of signals from receiver 14 is synchronized withthe transmission of electromagnetic waves by transmitter 24.

FIG. 2 shows a particular, slightly modified embodiment of receiver 14.FIG. 2A is a perspective, partly cut away view of probe 10 with receiver14 mounted in the housing 11 thereof. FIG. 2B is a circuit diagram ofreceiver 14. In this embodiment, sensor elements 16 a, 16 b, 18 a and 18b are coils of conducting wire wound on ferrite cores 70. Coils 16 a and16 b are mutually parallel. Coils 18 a and 18 b are mutually paralleland are perpendicular to coils 16 a and 16 b. Coils 16 a, 16 b, 18 a and18 b all are perpendicular to axis 12. Instead of sensor 20 with twosensor elements 20 a and 20 b, the embodiment of FIG. 2 has a singlecoil 20′ of conducting wire wound on a ferrite core 70. Coil 20′ isparallel to axis 12 and therefore is perpendicular to coils 16 a, 16 b,18 a and 18 b. Coil 20′ is centered on reference point 22. Sensors 16,18 and 20′ are connected to reception circuitry 34 by twisted wire pairs38. As shown in the circuit diagram of FIG. 2B, coils 16 a and 16 b areconnected in series, and coils 18 a and 18 b are connected in series.

Because sensors 16, 18 and 20′ of FIG. 2 all measure field components atthe same reference point 22, coils 16 a, 16 b, 18 a, 18 b and 20′ can bewound on ferrite cores 70 instead of the air cores of WO 96/05768without causing undue distortion of the received signals, despite thesmall transverse interior diameter 72, typically less than twomillimeters, of probe 10 when probe 10 is a catheter.

Wire pairs 38 are twisted in order to suppress electromagnetic couplingbetween wire pairs 38 and the environment, and in particular to suppresselectromagnetic coupling between wire pairs 38 and transmitter 24. FIG.2C is a circuit diagram that shows further features of the presentinvention that suppress this electromagnetic coupling. FIG. 2C is drawnwith particular reference to sensor 16, but the same features apply,mutatis mutandis, to sensor 18.

Coils 16 a and 16 b are connected in series by inner leads 116 a and 116b thereof. Outer lead 216 a of coil 16 a is connected, by wire 38 a oftwisted wire pair 38, to a positive input 126 a of a differentialamplifier 128 of reception circuitry 34. Outer lead 216 b of coil 16 bis connected, by wire 38 b of twisted wire pair 38, to a negative input126 b of differential amplifier 128. Inner leads 116 a and 116 b alsoare connected to ground 124 by a wire 122. For illustrational clarity,wire 38 a is drawn as a solid line, wire 38 b is drawn as a dotted lineand wire 122 is drawn as a dashed line.

FIG. 15 is a partial exploded perspective view of a preferred embodimentof probe 10 and receiver 14. Housing 11 is substantially cylindrical,with two recesses 511 and 513 incised therein. The boundary of eachrecess 511 or 513 includes a pair of diametrically opposed apertures:apertures 510 and 512 in the boundary of recess 511 and apertures 514and 516 in the boundary of recess 513. Arrows 530 and 532 show two ofthe three components of a cylindrical coordinate system for describingposition within and along housing 11. Arrow 530 points in thelongitudinal direction. Arrow 532 points in the azimuthal direction.Aperture pair 510, 512 is displaced both longitudinally and azimuthallyfrom aperture pair 514, 516.

Coil 16 a is a coil of electrically conducting wire that is wound abouta core 70 a. Core 70 a is mounted in apertures 514 and 516: end 518 ofcore 70 a, that extends beyond coil 16 a, is mounted in aperture 514 andis secured rigidly in place by a suitable glue, and end 520 of core 70a, that extends beyond coil 16 a in the opposite direction, is mountedin aperture 516 and is secured rigidly in place by a suitable glue.Similarly, coil 18 a is a coil of electrically conducting wire that iswound about a core 70 b. Core 70 b is mounted in apertures 510 and 512:end 522 of core 70 b, that extends beyond coil 18 a, is mounted inaperture 510 and is secured rigidly in place by a suitable glue, and end524 of core 70 b, that extends beyond coil 18 a in the oppositedirection, is mounted in aperture 512 and is secured rigidly in place bya suitable glue.

FIG. 15 also shows the preferred azimuthal separation of aperture pair514, 516 from aperture pair 510, 512. Aperture pair 514, 516 isperpendicular to aperture pair 510, 512, in the sense that aperture pair514, 516 is displaced 90°, in the direction of arrow 532, from aperturepair 510, 512. This makes core 70 a perpendicular to core 70 b, andhence makes coils 16 a and 18 a mutually perpendicular.

In the case of probe 10 being a catheter for invasively probing ortreating a body cavity such as a chamber of the heart, it is preferablethat housing 11 be made of a nonmagnetic metal such as nitinol,titanium, iconel, phynox or stainless steel. Housing 11 thus issufficiently flexible to bend under the lateral forces of the walls ofblood vessels through which probe 10 is inserted towards the bodycavity, and sufficiently resilient to return to its unstressed shape,with coils 16 a and 18 a mutually perpendicular, when the portion ofprobe 10 that includes receiver 14 reaches the interior of the bodycavity. Surprisingly, it has been found that the use of a conductivemetal as the material of housing 11 does not distort the electromagneticfield sensed by receiver 14 despite the current eddies induced inhousing 11 by the electromagnetic waves generated by transmitter 24.Apertures 510, 512, 514 and 516 are most conveniently formed by lasercutting. The accuracy of the mutual perpendicularity of coils 16 a and18 a obtained in this manner has been found to be superior to theaccuracy obtained by forming housing 11 as a solid cylindrical block anddrilling mutually perpendicular recesses in the block to receive coils16 a and 18 a.

Coils 16 b and 18 b are mounted similarly in similar pairs ofdiametrically opposed, azimuthally and longitudinally displacedapertures. This ensures that coils 16 a and 16 b are mutually parallel,that coils 18 a and 18 b are mutually parallel, and that coils 16 b and18 b are mutually perpendicular.

In an alternative structure (not shown) of housing 11, housing 11 isformed as an open, spring-like frame that includes apertures 510, 512,514 and 516 in the form of small rings that are sized to accept the ends518, 520, 522 and 524 of cores 70 a and 70 b. The spring-like nature ofthis embodiment of housing 11 allows coils 16 a and 18 a to be mountedtherein simply by forcing ends 518, 520, 522 and 524 into theirrespective apertures, and also allows housing 11 to flex duringinsertion towards a body cavity of a patient and to return to itsunstressed shape upon arrival inside the body cavity.

FIG. 3 is an axial sectional view of receiver 14 mounted in a variant ofprobe 10 that has two sections 10a and 10b connected by a flexibleconnector 40. As in FIG. 2, sensors 16 and 18 include sensor elements 16a, 16 b, 18 a and 18 b that are coils of conducting wire wound on aircores and that are perpendicular to axis 12. Sensor elements 16 a and 16b are mutually parallel, sensor elements 18 a and 18 b are mutuallyparallel, and sensor elements 16 a and 16 b are perpendicular to sensorelements 18 a and 18 b. Sensor 20 includes two sensor elements: coils 20a and 20 b of conducting wire wound on air cores. Coils 20 a and 20 bare equidistant from reference point 22 and are parallel to axis 12.Like coils 16 a and 16 b and like coils 18 a and 18 b, coils 20 a and 20b are connected in series. Flexible connector 40 allows this variant ofprobe 10 to bend as this variant of probe 10 is moved within a medicalpatient. Sensor element pairs 16, 18 and 20 are disposed symmetricallywith respect to reference point 22 in the sense that when probe 10 ofFIG. 3 is straight, as drawn, sensor elements 16 a and 16 b are onopposite sides of, and equidistant from, reference point 22; andlikewise sensor elements 18 a and 18 b are on opposite sides of, and areequidistant from, reference point 22; and sensor elements 20 a and 20 bare on opposite sides of, and are equidistant from, reference point 22.Note that when probe 10 of FIG. 3 is straight, sensor elements 16 a, 16b, 18 a, 18 b, 20 a and 20 b all are collinear, along axis 12 thatintersects point 22, and so are disposed symmetrically with respect topoint 22.

For coil pairs such as pairs 16 a and 16 b to produce signalsrepresentative of a magnetic field component at point 22 when the coilpairs are connected as shown in FIG. 2A, the two coils must haveopposite helicity, as illustrated in FIG. 4A, so that, in a spatiallyuniform time varying magnetic field, the signals induced in the two coilpairs 16 a and 16 b reinforce each other instead of canceling eachother. Coil pairs 16 a and 16 b that have identical helicities, asillustrated in FIG. 4B, may be used to measure a magnetic fieldcomponent gradient at point 22. Alternatively, coil pairs of identicalhelicities may be used to measure magnetic field components if the topof one coil is connected to the bottom of the other coil.

FIG. 5 illustrates a second class of preferred embodiments of receiver14. In FIG. 5, a conceptual cylindrical surface is denoted by dashedlines 42 and dashed circles 44. The embodiment of receiver 14illustrated in FIG. 5 includes three sensors 16, 18 and 20, each withtwo sensor elements 16 c and 16 d, 18 c and 18 d, and 20 c and 20 d,respectively. Each sensor element is a flat rectangular coil, of manyturns of conducting wire, that is bent into an arcuate shape to conformto the shape of the cylindrical surface. Sensor elements 16 c, 18 c and20 c are interleaved around circle 44 a. Sensor elements 16 d, 18 d and20 d are interleaved around circle 44 b. Sensor elements 16 c and 16 dare disposed symmetrically with respect to reference point 22, meaningthat sensor elements 16 c and 16 d are on opposite sides of referencepoint 22, are equidistant from reference point 22, and are oriented sothat an appropriate 180° rotation about point 22 maps sensor 16 c intosensor 16 d. Similarly, sensor elements 18 c and 18 d are disposedsymmetrically with respect to reference point 22, and sensor elements 20c and 20 d are disposed symmetrically with respect to reference point22. Sensor elements 16 c and 16 d are connected in series, in a mannersimilar to sensor elements 16 a and 16 b, to respond to one component ofthe magnetic field. Sensor elements 18 c and 18 d are connectedsimilarly in series to respond to a second component of the magneticfield that is independent of the first component, and sensor elements 20c and 20 d are connected similarly in series to respond to a thirdcomponent of the magnetic field that is independent of the first twocomponents. Most preferably, sensor elements 16 c, 16 d, 18 c, 18 d, 20c and 20 d are sized and separated so that these three magnetic fieldcomponents are orthogonal. In practice, the cylindrical surfacewhereabout sensor elements 16 c, 16 d, 18 c, 18 d, 20 c and 20 d aredisposed could be the inner surface of probe 10 or the outer surface ofa cylindrical sleeve adapted to fit inside probe 10. In the case of thisembodiment of receiver 14 formed on the outer surface of a cylindricalsleeve, sensor elements 16 c, 16 d, 18 c, 18 d, 20 c and 20 d may befabricated by any one of several standard methods, includingphotolithography and laser trimming. FIG. 10 illustrates the preferredgeometry of sensor elements 16 c, 16 d, 18 c, 18 d, 20 c and 20 d: aflat rectangular spiral 17 of an electrical conductor 19. Only fourturns are shown in spiral 17, for illustrational simplicity. Preferably,however, there are several hundred turns in spiral 17. For example, aspiral 17, intended for a cylindrical surface of a diameter of 1.6millimeters, in which conductor 19 has a width of 0.25 microns, and inwhich the windings are separated by gaps of 0.25 microns, has 167 turns.

FIGS. 12A, 12B and 12C illustrate the distal end of a cardiac catheter300 of the present invention. FIG. 12A is a partly cut-away perspectiveview of catheter 300 in the retracted position thereof. FIG. 12B is aperspective view of catheter 300 in the extended position thereof. FIG.12C is an end-on view of catheter 300 in the retracted position thereof.Catheter 300 includes a flexible cylindrical inner sleeve 302 slidablymounted in a flexible cylindrical outer sleeve 304. Connecting distalend 306 of inner sleeve 302 to distal end 308 of outer sleeve 304 arefour flexible rectangular strips 310. When inner sleeve 302 is in theextended position thereof relative to outer sleeve 304, strips 310 areflush against inner sleeve 302, as shown in FIG. 12B. When inner sleeve302 is in the retracted position thereof relative to outer sleeve 304,strips 310 bow outward in circular arcs, as shown in FIG. 12A.

Catheter 300 includes a set of three orthogonal electromagnetic fieldcomponent sensors 316, 318 and 320, in the manner of receiver 14 of FIG.1. First sensor 316 includes coils 316 a and 316 b mounted on oppositelateral edges 312 a and 314 a of strip 310 a and on opposite lateraledges 312 c and 314 c of strip 310 c. Coil 316 a is mounted on lateraledges 312 a and 312 c. Coil 316 b is mounted on lateral edges 314 a and314 b. Second sensor 318 includes coils 318 a and 318 b mounted onopposite lateral edges 312 b and 314 b of strip 310 b and on oppositelateral edges 312 d and 314 d of strip 310 d. Coil 318 a is mounted onlateral edges 312 b and 312 d. Coil 318 b is mounted on lateral edges314 b and 314 d. Third sensor 320 includes coils 320 a and 320 b. Innersleeve 302 is cut away in FIG. 12A to show coils 320 a and 320 b. Forillustrational clarity, the wires of coils 316 a and 318 a are shown inFIGS. 12A and 12B as dashed lines, and only two turns are shown for eachcoil, although in practice at least nine turns of 45-micron-diametercopper wire are used. Note that the wires of coil 316 a run throughinner sleeve 302, from lateral edge 312 a to lateral edge 312 c, and donot terminate at the intersection of lateral edges 312 a and 312 c withinner sleeve 302. Similarly, the wires of coil 318 a do not terminate atthe intersection of lateral edges 312 b and 312 d with inner sleeve 302,but instead run from lateral edge 312 b to lateral edge 312 d. Also forillustrational clarity, lateral edges 312 are shown much wider than theyreally are in preferred embodiments of catheter 300. Coils 320 a and 320b are wound around a permeable core (not shown).

In a typical embodiment of catheter 300, the length of inner sleeve 302exceeds the length of outer sleeve 304 by 15.7 mm in the extendedposition. Also in a typical embodiment of catheter 300, each of coils320 a and 320 b is about 1.1 mm long and about 1.1 mm in diameter andincludes about 400 turns of 10 micron diameter copper wire.

Coils 320 a and 320 b are parallel and equidistant from a central point322. When catheter 300 is opened to the retracted position thereof, asshown in FIGS. 12A and 12C, the circular arcs formed by strips 310 areconcentric with point 322. This makes coils 316 a, 316 b, 318 a and 318b circular and concentric with point 322, with coils 316 a and 316 bbeing mutually parallel, and with coils 318 a and 318 b being mutuallyparallel, so that point 322 then becomes the reference point forelectromagnetic field measurements.

In the extended position thereof, catheter 300 is thin enough,preferably less than about 2 mm in diameter, to be inserted via theblood vessels of a patient into the patient's heart. Once the distal endof catheter 300 is inside the desired chamber of the patient's heart,inner sleeve 302 is withdrawn relative to outer sleeve 304 to putcatheter 300 in the retracted position thereof. Sensors 316, 318 and 320are used in conjunction with transmitter 24 in the manner describedbelow to determine the location and orientation of the distal end ofcatheter 300 within the patient's heart.

Mounted on outward faces 324 of strips 310 are four electrodes 326.Mounted on distal end 306 of inner sleeve 302 is an electrode 328.Electrodes 326 and 328 may be used for electrophysiologic mapping of thepatient's heart. Alternatively, high RF power levels may be applied toselected heart tissue via electrode 328 to ablate that tissue in thetreatment of conditions such as ventricular tachycardia.

FIGS. 13A and 13B illustrate the distal end of an alternative embodiment400 of the cardiac catheter of the present invention. FIG. 13A is apartly cut-away side view of catheter 400 in the retracted positionthereof. FIG. 13B is an end-on view of catheter 400 in the retractedposition thereof. Like catheter 300, catheter 400 includes a flexiblecylindrical inner sleeve 402 slidably mounted in a flexible cylindricalouter sleeve 404. Connecting distal end 406 of inner sleeve 402 todistal end 408 of outer sleeve 404 is a single flexible member: aninflatable latex balloon 410. When inner sleeve 402 is in the extendedposition thereof relative to outer sleeve 404, balloon 410 is flushagainst inner sleeve 402. After the illustrated distal end of catheter400 has been introduced to the targeted chamber of a patient's heart,inner sleeve 402 is withdrawn to the retracted position thereof, andballoon 410 is inflated to assume a spherical shape.

Like catheter 300, catheter 400 includes a set of three orthogonalelectromagnetic field component sensors 416, 418 and 420, in the mannerof receiver 14 of FIG. 1. First sensor 416 includes parallel coils 416 aand 416 b mounted as shown on outer surface 412 of balloon 410. Secondsensor 418 includes parallel coils 418 a and 418 b mounted orthogonallyto coils 416 a and 416 b on outer surface 412, as shown. Third sensor420 includes coils 420 a and 420 b. Balloon 410 and inner sleeve 402 arecut away in FIG. 13A to show coils 420 a and 420 b. Coils 420 a and 420b are parallel and equidistant from a central point 422. When catheter400 is opened to the retracted position thereof and balloon 410 isinflated to a spherical shape, outer surface 412 is a sphere concentricwith point 422. This makes coils 416 a, 416 b, 418 a and 418 b circularand concentric with point 422, so that point 422 then becomes thereference point for electromagnetic field measurements.

Also as in the case of catheter 300, catheter 400 includes fourelectrodes 426, similar to electrodes 326, mounted on outer surface 412,and an electrode 428, similar to electrode 328, mounted on distal end406 of inner sleeve 402.

FIG. 6 is a plan view of loop antennas 26, 28 and 30. Loop antenna 26 isa rectangle with legs 26 a, 26 b, 26 c and 26 d. Loop antenna 28 is arectangle of the same shape and size as loop antenna 26, and with legs28 a, 28 b, 28 c and 28 d. Legs 26 b and 28 d are adjacent. Loop antenna30 also is rectangular, with legs 30 a, 30 b, 30 c and 30 d. Leg 30 aoverlies legs 26 a and 28 a; leg 30 b overlies the upper half of leg 28b; and leg 30 d overlies the upper half of leg 26 d, so that loopantenna 30 overlaps half of loop antenna 26 and half of loop antenna 28.Also shown in phantom in FIG. 6 is a fourth rectangular loop antenna 46and a fifth rectangular loop antenna 48 that are not part of transmitter24 but are referred to in the explanation below. Loop antenna 46 is ofthe same shape and size as loop antenna 30, and overlaps the halves ofloop antennas 26 and 28 that are not overlapped by loop antenna 30. Loopantenna 48 matches the outer perimeter defined by loop antennas 26 and28.

To understand the preferred mode of the operation of the system of thepresent invention, it is helpful to consider first a less preferredmode, based on time domain multiplexing, of operating a similar systemthat includes all five loop antennas of FIG. 6. In this less preferredmode, loop antenna 48 is energized using a sinusoidal current of angularfrequency ω₁. Then, loop antennas 26 and 28 are energized by oppositelydirected sinusoidal currents of angular frequency ω₁. Finally, loopantennas 30 and 46 are energized by oppositely directed sinusoidalcurrents of angular frequency ω₁. The idea of this energization sequenceis to produce, first, a field above the transmitter that is spatiallysymmetric in both the horizontal and the vertical direction as seen inFIG. 6, then a field above the transmitter that is antisymmetric in thehorizontal direction and symmetric in the vertical direction, andfinally a field that is symmetric in the horizontal direction andantisymmetric in the vertical direction. These three fields are linearlyindependent, and all three fields have significant amplitude all the wayacross the transmitter. The signals output by the three sensors ofreceiver 14 in response to the electromagnetic waves so generated aresampled at times t_(m) by reception circuitry 34. The sampled signalsare:s ⁰ _(im) =c ⁰ _(i,1) cos ω₁ t _(m) +c ⁰ _(i,2) sin ω₁ t _(m) from loopantenna 48s ^(h) _(im) =c ^(h) _(i,1) cos ω₁ t _(m) +c ^(h) _(i,2) sin ω₁ t _(m)from loop antenna 26 and 28s ^(v) _(im) =c ^(v) _(i,1) cos ω₁ t _(m) +c ^(v) _(i,2) sin ω₁ t _(m)from loop antenna 30 and 46where i indexes the sensor that receives the corresponding signal.Coefficients c⁰ _(i,1), c^(h) _(i,1) and c^(v) _(i,1) are the in-phaseamplitudes of the received signals. Coefficients c⁰ _(i,2), c^(h) _(i,2)and c^(v) _(i,2) are the quadrature amplitudes of the received signals.Because ω₁ is sufficiently low that receiver 14 is in the near fieldsgenerated by the loop antennas, in principle the quadrature amplitudesshould be identically zero. Because of inevitable phase distortions, forexample in reception circuitry 34, the quadrature amplitudes generallyare not zero.

Note that amplitudes c⁰ _(i,j), c^(h) _(i,j) and c^(v) _(i,j)(j=1,2)could be obtained by using only loop antennas 26, 28 and 30. Thesampled signals obtained by energizing loop antennas 26, 28 and 30separately with identical sinusoidal currents of angular frequency ω₁are:s ¹ _(im) =c ¹ _(i) cos ω₁ t _(m) +c ² _(i) sin ω₁ t _(m) from loopantenna 26s ² _(im) =c ³ _(i) cos ω₁ t _(m) +c ⁴ _(i) sin ω₁ t _(m) from loopantenna 28s ³ _(im) =c ⁵ _(i) cos ω₁ t _(m) +c ⁶ _(i) sin ω₁ t _(m) from loopantenna 30the coefficients c¹ _(i), c³ _(i) and c⁵ _(i) being in-phase amplitudesand the coefficients c² _(i), c⁴ _(i) and c⁶ _(i) being quadratureamplitudes. Because the field radiated by loop antennas 26 and 28 whenidentical currents J flow therein is the same as the field generated byloop antenna 48 when current J flows therein,c ⁰ _(i,1) =c ¹ _(i) +c ³ _(i)  (1)c ⁰ _(i,2) =c ² _(i) +c ⁴ _(i)  (2)By definition,c ^(h) _(i,1) =c ¹ _(i) −c ³ _(i)  (3)c ^(h) _(i,2) =c ² _(i) −c ⁴ _(i)  (4)Finally, the fact that the field radiated by loop antenna 48 could alsobe emulated by identical currents flowing through loops 30 and 46 givesc ^(v) _(i,1)=2c ⁵ _(i) −c ¹ _(i) −c ³ _(i)  (5)c ^(v) _(i,2)=2c ⁶ _(i) −c ² _(i) −c ⁴ _(i)  (6)

In the preferred mode of the operation of the system of the presentinvention, loop antennas 26, 28 and 30 are energized simultaneously withsinusoidal currents of angular frequencies ω₁, ω₂ and ω₃, respectively.The sampled signals now ares _(im) =c _(i1) cos ω₁ t _(m) +c _(i2) sin ω₁ t _(m) +c _(i3) cos ω₂ t_(m) +c _(i4) sin ω₂ t _(m) +c _(i5) cos ω₃ t _(m) +c _(i6) sin ω₃ t_(m)  (7)Note that now, amplitudes c_(i1) and c_(i2) refer to frequency ω₁,amplitudes c_(i3) and c_(i4) refer to frequency ω₂, and amplitudesc_(i5) and c_(i6) refer to frequency ω₃. The sampled signals areorganized in a matrix s of three rows, one row for each sensor ofreceiver 14, and as many columns as there are times t_(m), one columnper time. Amplitudes c_(ij) are organized in a matrix c of three rowsand six columns. The matrices s and c are related by a matrix A of sixrows and as many columns as there are in matrix s:s=cA  (8)Almost always, there are many more than six columns in matrix s, makingequation (8) highly overdetermined. Because the transmission frequenciesand the reception times are known, matrix A is known. Equation (8) issolved by right-multiplying both sides by a right inverse of matrix A: amatrix, denoted as A⁻¹, such that AA⁻¹=I, where I is the 6×6 identitymatrix. Right inverse matrix A⁻¹ is not unique. A particular rightinverse matrix A⁻¹ may be selected by criteria that are well known inthe art. For example, A⁻¹ may be the right inverse of A of smallest L²norm. Alternatively, matrix c is determined as the generalized inverseof equation (8):c=sA ^(T)(AA ^(T))⁻¹  (9)where the superscript “T” means “transpose”. The generalized inverse hasthe advantage of being an implicit least squares solution of equation(8).

In the special case of evenly sampled times t_(m), solving equation (8)is mathematically equivalent to the cross-correlation of WO 96/05768.Equation (8) allows the sampling of the signals from receiver 14 atirregular times. Furthermore, there is no particular advantage to usingfrequencies ω₁, ω₂ and ω₃ that are integral multiples of a basefrequency. Using closely spaced frequencies has the advantage ofallowing the use of narrow-band filters in reception circuitry 34, atthe expense of the duration of the measurement having to be at leastabout 2π/Δω, where Δω is the smallest frequency spacing, except in thespecial case of two signals of the same frequency and different phases.

Because receiver 14 is in the near field of transmitter 24, coefficientsc_(ij) of equation (7) are the same as coefficients c^(j) _(i). Itfollows that equations (1)-(6) still hold, and either of two 3×3matrices M can be formed from the elements of matrix c for furtherprocessing according to the description in co-pending Israel PatentApplication 122578, an in-phase matrix $\begin{matrix}{M = \begin{pmatrix}c_{1,1}^{0} & c_{1,1}^{h} & c_{1,1}^{v} \\c_{2,1}^{0} & c_{2,1}^{h} & c_{2,1}^{v} \\c_{3,1}^{0} & c_{3,1}^{h} & c_{3,1}^{v}\end{pmatrix}} & (10)\end{matrix}$or a quadrature matrix $\begin{matrix}{M = \begin{pmatrix}c_{1,2}^{0} & c_{1,2}^{h} & c_{1,2}^{v} \\c_{2,2}^{0} & c_{2,2}^{h} & c_{2,2}^{v} \\c_{3,2}^{0} & c_{3,2}^{h} & c_{3,2}^{v}\end{pmatrix}} & (11)\end{matrix}$Note that because the system of the present invention is a closed-loopsystem, there is no sign ambiguity in M, unlike the corresponding matrixof co-pending Israel Patent Application 122578.

Let T be the orthonormal matrix that defines the rotation of probe 10relative to the reference frame of transmitter 24. Write M in thefollowing form:M=ET₀T  (12)where T₀ is an orthogonal matrix and E is in general a nonorthogonalmatrix. In general, T₀ and E are functions of the position of probe 10relative to the reference frame of transmitter 24. LetW²=MM^(T)=ET₀TT^(T)T₀ ^(T)E^(T)=EE^(T)  (13)W² is real and symmetric, and so can be written asW²=Pd²P^(T)=(PdP^(T))², where d² is a diagonal matrix whose diagonalelements are the (real and positive) eigenvalues of W² and where P is amatrix whose columns are the corresponding eigenvectors of W². ThenW=PdP^(T)=E also is symmetric. Substituting in equation (12) gives:M=PdP^(T)T₀T  (14)so thatT=T₀ ^(T)Pd⁻¹P^(T)M  (15)If T₀ is known, then T, and hence the orientation of probe 10 withrespect to the reference frame of transmitter 24, can be computed usingequation (15).

For any particular configuration of the antennas of transmitter 24, T₀may be determined by either of two different calibration procedures.

In the experimental calibration procedure, probe 10 is oriented so thatT is a unit matrix, probe 10 is moved to a succession of positionsrelative to transmitter 24, and M is measured at each position. TheequationT₀=Pd⁻¹P^(T)M  (16)gives T₀ at each of those calibration positions.

There are two variants of the theoretical calibration procedure, both ofwhich exploit reciprocity to treat receiver 14 as a transmitter andtransmitter 24 as a receiver. The first variant exploits the principleof reciprocity. The sensor elements are modeled as point sources,including as many terms in their multipole expansions as are necessaryfor accuracy, and their transmitted magnetic fields in the plane oftransmitter 24 are calculated at a succession of positions relativethereto, also with probe 10 oriented so that T is a unit matrix. The EMFinduced in the antennas of transmitter 24 by these time-varying magneticfields is calculated using Faraday's law. The transfer function ofreception circuitry 34 then is used to compute M at each calibrationposition, and equation (16) gives T₀ at each calibration position. Inthe second variant, the magnetic field generated by each antenna oftransmitter 24 at the three frequencies ω₁, ω₂ and ω₃ is modeled usingthe Biot-Savart law. Note that each frequency corresponds to a differentsensor 16, 18 or 20. The signal received at each sensor is proportionalto the projection of the magnetic field on the sensitivity direction ofthe sensor when object 10 is oriented so that T is a unit matrix. Thisgives the corresponding column of M up to a multiplicative constant andup to a correction based on the transfer function of reception circuitry34.

To interpolate T₀ at other positions, a functional expression for T₀ isfitted to the measured values of T₀. Preferably, this functionalexpression is a polynomial. It has been found most preferable to expressthe Euler angles α, β and γ that define T₀ as the following 36-termpolynomials. The arguments of these polynomials are not direct functionsof Cartesian coordinates x, y and z, but are combinations of certainelements of matrix W that resemble x, y and z, specifically,a=W₁₃/(W₁₁+W₃₃), which resembles x; b=W₂₃/(W₂₂+W₃₃), which resembles y,and c=log(1/W₃₃), which resembles z. Using a direct product notation,the 36-term polynomials can be expressed as:α=(a, a ³ , a ⁵)(b, b ³ , b ⁵)(1, c, c ² , c ³)AZcoe  (17)β=(a, a ³ , a ⁵)(1, b ² , b ⁴ , b ⁶)(1, c, c ²)ELcoe  (18)γ=(1, a ² , a ⁴ ,a ⁶)(b, b ³ , b ⁵)(1, c, c ²)RLcoe  (19)where AZcoe, ELcoe and RLcoe are 36-component vectors of the azimuthcoefficients, elevation coefficients and roll coefficients that arefitted to the measured or calculated values of the Euler angles. Notethat to fit these 36-component vectors, the calibration procedure mustbe carried out at at least 36 calibration positions. At each calibrationposition, W is computed from M using equation (13), and theposition-like variables a, b and c are computed from W as above.

Similarly, the Cartesian coordinates x, y and z of probe 10 relative tothe reference frame of transmitter 24 may be expressed as polynomials.It has been found most preferable to express x, y and z as the following36-term polynomials:x=(a, a ³ , a ⁵)(1, b, b ⁴)(1, c, c ² , c ³)Xcoe  (20)y=(1, a ² , a ⁴)(b, b ³ , b ⁵)(1, c, c ² , c ³)Ycoe  (21)z=(1, a ² , a ⁴)(1, b ² , b ⁴)(1, d, d ² , d ³)Zcoe  (22)where Xcoe, Ycoe and Zcoe are 36-component vectors of thex-coefficients, the y-coefficients, and the z-coefficients,respectively; and d=log(c). As in the case of the Euler angles, theseposition coordinate coefficients are determined by either measuring orcomputing M at at least 36 calibration positions and fitting theresulting values of a, b and c to the known calibration values of x, yand z. Equations (17) through (22) may be used subsequently to infer theCartesian coordinates and Euler angles of moving and rotating probe 10noniteratively from measured values of M.

Although the antenna configuration illustrated in FIGS. 1 and 6 is themost preferred configuration, other configurations fall within the scopeof the present invention. FIGS. 7A, 7B and 7C show three alternativeconfigurations of paired adjacent loop antennas 26′ and 28′. The arrowsindicate the direction of current flow that emulates a single loopantenna coincident with the outer perimeter of antennas 26′ and 28′.Other useful coplanar overlapping antenna configurations are describedin PCT Publication No. WO 96/03188, entitled “Computerized game Board”,which is incorporated by reference for all purposes as if fully setforth herein.

FIG. 8 is a schematic block diagram of driving circuitry 32 for drivinga generic antenna 25 that represents any one of loop antennas 26, 28 or30. A digital signal generator 50 generates samples of a sinusoid thatare converted to an analog signal by a D/A converter 52. This analogsignal is amplified by an amplifier 54 and sent to the positive input 60of a differential amplifier 58. Loop antenna 25 is connected both to theoutput 64 of differential amplifier 58 and to the negative input 62 ofdifferential amplifier 58. Negative input 62 also is grounded via aresistor 66. The feedback loop thus set up drives antenna 25 at thefrequency of the sinusoid generated by signal generator 50, and makesantenna 25 appear to be an open circuit at all other frequencies.

Unlike the circuitry of WO 97/36143, which acts to offset the influenceof one loop antenna on another, the circuitry of FIG. 8 decouples loopantenna 25 from the other loop antennas. The superiority of the presentinvention over WO 97/36143 is evident. Consider, for example, how WO97/36143 and the present invention correct for the mutual inductances ofloop antenna 26, radiating at a frequency ω₁, and loop antenna 30,radiating at a frequency ω₂. The goal is to set up the field offrequency ω₁ that would be present if only loop antenna 26, and not loopantenna 30, were present, and to set up the field of frequency ω₂ thatwould be present if only loop antenna 30, and not loop antenna 26, werepresent. By Faraday's and Ohm's laws, the time rate of change of themagnetic flux through loop antenna 26 is proportional to the currentthrough loop antenna 26, and the time rate of change of the magneticflux through loop antenna 30 is proportional to the current through loopantenna 30. In the absence of loop antenna 30, loop antenna 26 sets up acertain time-varying magnetic flux of frequency ω₁ across the area thatwould be bounded by loop antenna 30 if loop antenna 30 were present. Themethod of WO 97/36143 forces the time rate of change of this magneticflux through loop antenna 30 to be zero. Because the magnetic flux hasno DC component, the magnetic flux itself through loop antenna 30therefore also vanishes, which is contrary to the situation in theabsence of loop antenna 30. By contrast, the present invention makesloop antenna 30 appear to be an open circuit at frequency ω₁ and so doesnot change the magnetic flux from what it would be in the absence ofloop antenna 30.

FIG. 9 shows, schematically, a C-mount fluoroscope 80 modified accordingto the present invention for simultaneous real-time image acquisitionand intrabody navigation. Fluoroscope 80 includes the conventionalcomponents of a C-mount fluoroscope: an x-ray source 82 and an imageacquisition module 84 mounted on opposite ends of a C-mount 78, and atable 86 whereon the patient lies. Image acquisition module 84converting x-rays that transit the patient on table 86 into electronicsignals representative of a 2D image of the patient. C-mount 78 ispivotable about an axis 76 to allow the imaging of the patient fromseveral angles, thereby allowing the reconstruction of a 3D image of thepatient from successive 2D images. In addition, either a receiver 114,similar to receiver 14, or transmitter 24, is rigidly mounted on C-mount78. Receiver 114 or transmitter 24 serves to define a frame of referencethat is fixed relative to C-mount 78. The other components shown in FIG.1, i.e., driving circuitry 32, reception circuitry 34, andcontrol/processing unit 36, are connected to transmitter 24 and toreceiver 14 in probe 10 as described above in connection with FIG. 1. Inaddition, signals from receiver 114 that correspond to theelectromagnetic waves generated by transmitter 24′ are sent to receptioncircuitry 134 that is identical to reception circuitry 34, andcontroller/processor 36 directs the reception of received signals byreception circuitry 134 and the acquisition of an image of the patientby image acquisition module 84 of fluoroscope 80.

By determining the position and orientation of probe 10 relative to theframe of reference defined by transmitter 24, controller/processor 36determines the position and orientation of probe 10 relative to eachacquired 2D image. Alternatively, the electromagnetic signals aretransmitted by a transmitter 24′ that is not attached to C-mount 78, andcontroller/processor 36 determines the position and orientation of probe10 relative to the 2D images by determining the positions andorientations of receivers 14 and 114 relative to transmitter 24′.Controller/processor 36 synthesizes a combined image that includes boththe 3D image of the patient acquired by fluoroscope 80 and an iconrepresenting probe 10 positioned and oriented with respect to the 3Dimage of the patient in the same way as probe 10 is positioned andoriented with respect to the interior of the patient.Controller/processor 36 then displays this combined image on a monitor92.

C-mount fluoroscope 80 is illustrative rather than limitative. The scopeof the present invention includes all suitable devices for acquiring 2Dor 3D images of the interior of a patient, in modalities including CT,MRI and ultrasound in addition to fluoroscopy.

Under certain circumstances, the image acquisition and the intrabodynavigation may be done sequentially, rather than simultaneously. This isadvantageous if the medical imaging facilities and the medical treatmentfacilities can not be kept in the same location. For example, the humanskull is sufficiently rigid that if a receiver of the present inventionis rigidly mounted on the head of a patient using an appropriateheadband, then the position and orientation of the receiver is asufficient accurate representation of the position and orientation ofthe patient's head to allow intracranial navigation. FIG. 11 shows ahead 94 of a patient inside a (cut-away) CT scanner 98. As in the caseof fluoroscope 80 of FIG. 9, receiver 114 and transmitter 24 are rigidlyattached to CT scanner 98, transmitter 24 being so attached via an arm100. CT scanner 98 acquires 2D x-ray images of successive horizontalslices of head 94. A receiver 214 is rigidly mounted on head 94 using aheadband 96. As the 2D images are acquired, the position and orientationof receiver 214 with respect to each image is determined by the methodsdescribed above for determining the position and orientation of probe 10with respect to the 2D images acquired by fluoroscope 80. Thesepositions and orientations are stored, along with the 2D images, incontrol/processing unit 36. Subsequently, during medical treatment ofhead 94 that requires navigation of probe 10 through head 94, theposition and orientation of probe 10 in head 94 is determined usingsignals from receivers 14 and 214 in the manner described above forpositioning and orienting probe 10 with respect to C-mount 78 offluoroscope 80 using receivers 14 and 114. Given, now, for each 2D CTimage, the position and orientation of probe 10 with respect to receiver214 and the position and orientation of receiver 214 with respect tothat 2D image, it is trivial to determine the position and orientationof probe 10 with respect to that 2D image. As in the case of thesimultaneous imaging and navigation depicted in FIG. 9,controller/processor 36 now synthesizes a combined image that includesboth the 3D image of head 94 acquired by CT scanner 98 and an iconrepresenting probe 10 positioned and oriented with respect to the 3Dimage of head 94 in the same way as probe 10 is positioned and orientedwith respect to head 94. Controller/processor 36 then displays thiscombined image on monitor 92.

As in the case of fluoroscope 80, CT scanner 98 is illustrative ratherthan limitative. The scope of the present invention includes allsuitable devices for acquiring 2D or 3D images of a limb of a patient,in modalities including MRI, ultrasound and fluoroscopy in addition toCT. Note that this method of image acquisition followed by intrabodynavigation allows the a centrally located imaging device to serveseveral medical treatment facilities.

FIG. 14 is a partially exploded, partial perspective view of a C-mountfluoroscope 80′ modified according to one aspect of the presentinvention. Like C-mount fluoroscope 80, C-mount fluoroscope 80′ includesan x-ray source 84 and an image acquisition module 82 at opposite endsof a C-mount 78. Image acquisition module 82 includes an imageintensifier 83, a front face 85 whereof faces x-ray source 84, and a CCDcamera 87, mounted on the end of image intensifier 83 that is oppositefront face 85, for acquiring images that are intensified by imageintensifier 83. Image intensifier 83 is housed in a cylindrical housing91. In addition, fluoroscope 80′ includes an annular compensator 500made of a magnetically permeable material such as mu-metal.

The need for compensator 500 derives from the fact that front face 85 iselectrically conductive. The electromagnetic waves generated bytransmitter 24 or 24′ induce eddy currents in front face 85 that distortthe electromagnetic field sensed by receiver 14. Placing a mass of amagnetically permeable substance such as mu-metal in the proper spatialrelationship with front face 85 suppresses this distortion. This istaught, for example, in U. S. Pat. No. 5,760,335, to Gilboa, whichpatent is incorporated by reference for all purposes as if fully setforth herein, in the context of shielding a CRT from external radiationwithout perturbing the electromagnetic field external to the CRT.

Preferably, compensator 500 is a ring, 5 cm in axial length, of mu metalfoil 0.5 mm thick. Compensator 500 is slidably mounted on the externalsurface 89 of cylindrical housing 91, as indicated by double-headedarrows 504, and is held in place by friction. It is straightforward forone ordinarily skilled in the art to select a position of compensator500 on housing 91 that provides the optimal suppression of distortionsof the electromagnetic field outside image intensifier 83 due to eddycurrents in front face 85.

It often is desirable to retrofit a new apparatus such as receiver 14 toan existing catheter rather than to design a new probe 10 that includesboth the new apparatus and the functionality of an already existingprobe. This retrofit capability is particularly important if probe 10would have been used for medical applications, and both the apparatusand the existing probe had already been approved for medicalapplications by the relevant regulatory bodies. Such a retrofitcapability then would preclude the need to obtain regulatory approvalfor the new probe, a process that often is both expensive andtime-consuming.

FIG. 16 illustrates just such a retrofit capability, for adapting asatellite 550 to a substantially cylindrical catheter 552 for invasivelyprobing or treating a body cavity such as a chamber of the heart.Satellite 550 is an instrumentation capsule that may contain receiver 14or any other medically useful apparatus. For example, satellite 550 maycontain an apparatus for ablating cardiac tissue. A catheter such ascatheter 552 is introduced to the body cavity of a patient via thepatient's blood vessels, via an introducer sheath. It is important thatthe external diameter of the introducer sheath be minimized, to reducethe risk of bleeding by the patient. Consequently, the external diameterof catheter 552 also must be minimized, and any scheme for retrofittingsatellite 550 to catheter 552 must allow satellite 550 to be introducedinto the introducer sheath along with catheter 552. It is the latterrequirement that generally precludes simply attaching satellite 550 tocatheter 552. In addition, if satellite 550 includes receiver 14, withthe intention of using receiver 14 to track the position and orientationof catheter 550, then, when satellite 550 and catheter 552 are deployedwithin the body cavity, satellite 550 must have a fixed position andorientation relative to catheter 552.

The retrofitting scheme of FIG. 16 achieves these ends by providingsatellite 550 and catheter 552 with a mechanism for providing only aloose mechanical connection between satellite 550 and catheter 552 assatellite 550 and catheter 552 are introduced to the body cavity, andonly then securing satellite 550 to catheter 552 at a fixed position andorientation relative to catheter 552. FIG. 16A shows a thin flexibletether 554 attached to proximal end 556 of satellite 550. Tether 554provides a mechanical link to the outside of the patient. Depending onthe instrumentation installed in tether 554, tether 554 may also providea communications link to the outside of the patient. For example, ifsatellite 550 includes receiver 14, then extensions of wire pairs 38 areincluded in tether 554. Rigidly attached to tether 554 is a hollowcylindrical sleeve 558 whose inner diameter is the same as the outerdiameter of catheter 552.

The remainder of the mechanism for reversibly securing satellite 550 tocatheter 552 is shown in FIG. 16B. Catheter 552 is provided, near distalend 564 thereof, with a pocket 560 made of a flexible, resilient,elastic material. Pocket 560 is attached rigidly to the outer surface ofcatheter 552. Pocket 560 includes an aperture 562, which is adjacentcatheter 552 at the proximal end of catheter 552, and which accommodatestether 554. Pocket 560 is sized to accommodate satellite 550 snuglytherein via an opening in distal end 566 of pocket 560.

Satellite 550, catheter 552 and the associated securing mechanism areassembled as shown in FIG. 16C, with tether 554 running through aperture562, sleeve 558 encircling catheter 552 proximal of pocket 560, andsatellite 550 distal of pocket 560. Catheter 552 and tether 554 areshown emerging from the distal end of a protective jacket 568.Preferably, sleeve 558 is made of a low-friction material such asTeflon™, to allow sleeve 558 to slide freely along catheter 552. Theassembly shown in FIG. 16C is introduced to the introducer sheath withsatellite 550 in front of catheter 552. During this introduction, pocket560 is compressed against the outer surface of catheter 552 by theintroducer sheath. Tether 554 is sufficiently flexible to bend alongwith catheter 552 and jacket 568 as the assembly shown in FIG. 16Cpasses through the patient's blood vessels, but is sufficiently rigid topush satellite 550 ahead of distal end 564 of catheter 552 as catheter552 is inserted into the patient. As a result, satellite 550 and distalend 564 of catheter 552 reach interior of the targeted body cavity inthe configuration illustrated in FIG. 16C. At this point, pocket 560opens, and tether 554 is pulled to withdraw satellite 550 into pocket560 via the opening in distal end 566 of pocket 560. Satellite 550 andtether 554 now are held by pocket 560, sleeve 558 and jacket 568 in afixed position and orientation relative to catheter 552, as illustratedin FIG. 16D.

Subsequent to treatment, tether 554 is pushed to restore theconfiguration shown in FIG. 16C, to allow catheter 552 and satellite 550to be withdrawn from the patient.

While the invention has been described with respect to a limited numberof embodiments, it will be appreciated that many variations,modifications and other applications of the invention may be made.

1. A catheter, comprising: (a) a housing having a transverse innerdimension of at most about two millimeters; and (b) a coil arrangementincluding at least five coils and at least five solid cores, each ofsaid coils being wound around one of said cores, said coils beingnon-coaxial, said coil arrangement being mounted inside said housing. 2.The catheter of claim 1, wherein said solid cores includes ferrite. 3.The catheter of claim 1, wherein said coils have an axis, said axes ofat least three of said coils being substantially mutually perpendicularto each other.
 4. The catheter of claim 1, wherein each of said coilshas a center, said centers of said coils lying on a substantiallystraight line.
 5. A probe for interacting with a body cavity,comprising: (a) a substantially cylindrical catheter; (b) a satellite;being part of a sensing probe; (c) a flexible pocket having an aperturetherein, said flexible being rigidly, attached to said catheter, saidflexible pocket being configured for receiving said satellite therein;and (d) a tether passing through said aperture, said tether beingattached to said satellite, such that, after said catheter and saidsatellite have been inserted into the body cavity, said tether iswithdrawn, thereby pulling said satellite into said flexible pocket soas to reversibly secure said satellite at a fixed position andorientation relative to said catheter.
 6. The probe of claim 5, whereinsaid mechanism includes: (i) a sleeve, rigidly secured to said tetherand adapted to slide along said catheter.
 7. The probe of claim 5,wherein said sensor is configured for sensing a position and orientationof said catheter.